Job Title: Safety Writer III
Location: Remote, India
Company: Thermo Fisher Scientific
Employment Type: Full-time
Salary: ₹14 LPA – ₹26 LPA (Estimated)
Job Description
Thermo Fisher Scientific is hiring a Safety Writer III to support pharmacovigilance and clinical safety documentation across global clinical trials and marketed products. In this role, you will plan, coordinate, and deliver safety writing deliverables while ensuring compliance with regulatory standards and strict timelines.
You will collaborate with pharmacovigilance teams, global project stakeholders, and clients to ensure accurate safety reporting and regulatory documentation that supports patient safety and drug development.
Key Responsibilities
Conduct data review, authoring, quality review, and senior review of safety writing deliverables.
Manage and deliver a wide range of pharmacovigilance reports including:
PA(D)ERs (Periodic Adverse Drug Experience Reports)
DSURs (Development Safety Update Reports)
PSURs / PBRERs (Periodic Safety Update Reports / Periodic Benefit-Risk Evaluation Reports)
Risk Management Plans (RMPs)
Support regulatory submissions and customized safety documentation.
Lead safety writing projects and serve as the primary point of contact for assigned deliverables.
Collaborate with internal teams, clients, and third-party vendors.
Ensure compliance with company SOPs, regulatory guidelines, and contractual obligations.
Mentor junior staff and provide guidance on safety writing best practices.
Stay updated with global pharmacovigilance regulations and reporting requirements.
Participate in client meetings, audits, inspections, and project planning activities.
Required Qualifications
Bachelor’s degree or higher in a scientific discipline.
Minimum 6 years of experience in safety writing within pharmacovigilance or clinical research.
Experience authoring and reviewing key safety documents including:
DSURs
PBRERs / PSURs
PA(D)ERs
Risk Management Plans (RMPs)
Skills & Competencies
Strong knowledge of ICH and US aggregate safety reporting formats.
Expertise in global pharmacovigilance regulations and risk management planning.
Excellent medical-scientific writing, editing, and data interpretation skills.
Strong project management and organizational abilities.
Ability to manage multiple projects simultaneously.
Strong analytical thinking and problem-solving skills.
Excellent communication skills and attention to detail.
Advanced proficiency in Microsoft Office (Word, Excel, Outlook) and multiple clinical systems.
Ability to mentor junior team members and collaborate across global teams.
About the Company
Thermo Fisher Scientific is a global leader in scientific research services, supporting pharmaceutical and biotechnology companies in developing innovative therapies. Through its PPD® clinical research portfolio, the company helps bring life-saving medicines to market across more than 100 countries
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